VENTANNA ANTI-CD3 PRIMARY ANTIBODY

Lambda, Antigen, Antiserum, Control

VENTANA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ventana Medical Systems, Inc. with the FDA for Ventanna Anti-cd3 Primary Antibody.

Pre-market Notification Details

Device IDK941505
510k NumberK941505
Device Name:VENTANNA ANTI-CD3 PRIMARY ANTIBODY
ClassificationLambda, Antigen, Antiserum, Control
Applicant VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson,  AZ  85705
ContactStephen A Tillson
CorrespondentStephen A Tillson
VENTANA MEDICAL SYSTEMS, INC. 3865 N. BUSINESS CENTER DR. Tucson,  AZ  85705
Product CodeDEH  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-29
Decision Date1996-05-30
Summary:summary

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